UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020662
Receipt No. R000023839
Scientific Title Effect on snoring and feasibility of Nasal Airway Stent
Date of disclosure of the study information 2016/04/01
Last modified on 2020/01/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect on snoring and feasibility of Nasal Airway Stent
Acronym Effect and feasibility of Nasal Airway Stent
Scientific Title Effect on snoring and feasibility of Nasal Airway Stent
Scientific Title:Acronym Effect and feasibility of Nasal Airway Stent
Region
Japan

Condition
Condition Snoring
Classification by specialty
Medicine in general Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 (1) Examine feasibility of using Nasal Airway Stent
(1) Examine the effect of using Nasal Airway Stent on snoring
(1) Examine the effect of using Nasal Airway Stent on apnea or hypopnea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) feasibility of using Nasal Airway Stent
Before and After 4 days using Nasal Airway Stent, assessed for 3 days about
(2) snoring by digital voice recorder
(3) apnea and hypopnea (AHI) by Apnea hypopnea testing apparatus
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Nasal Airway Stent 7 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Subjects who approve to take part in the study as examinees after informed consent
Key exclusion criteria (1) Patient with sleep apnea syndrome undergoing medical treatment
(2) Patient with severe respiratory diseases
(3) Patient with severe liver, renal, heart, etc. diseases.
(4) Subject who cannot insert Nasal Airway Stent into the nasal cavity
(5) Subject who cannot perform examinations
(6) Subject judged as inadequate by researcher
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Sumi
Organization Tokyo Medical and Dental University
Division name School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Science
Zip code 113-8519
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL 03-5803-5372
Email ysumi.pulm@tmd.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Sumi
Organization Tokyo Medical and Dental University
Division name School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Sci
Zip code 113-8519
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL 03-5803-5372
Homepage URL
Email ysumi.pulm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
Tel 03-3813-6111
Email info.bec@tmd.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 20 Day
Date of IRB
2016 Year 03 Month 22 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.